FDA Issues Safety Alert on Liver Disease Drug

FDA Issues Safety Alert on Liver Disease Drug

Postmarketing data on obeticholic acid (Ocaliva) identified a risk for serious liver injury in primary biliary cholangitis (PBC) patients without

FDA flags additional injury risk for Intercept’s liver drug

The agency identified 20 cases of serious liver damage associated with Ocaliva in the latest setback for a drug once seen as a potential blockbuster.

FDA highlights injury risk for some patients on liver disease drug

FDA Warns of Ocaliva Liver Injury Risks Linked to Autoimmune Disorder Drug

The findings of a new study indicate that patients taking the autoimmune liver disease drug Ocaliva faced a nearly 400% increased risk of developing liver disease. The U.S. Food and Drug Administration (FDA) issued a drug safety communication on December 12, warning that Ocaliva can lead to serious liver injury among patients who do not already have liver disease and increases the likelihood of needing a liver transplant and death. Ocaliva (obet…

FDA Identifies New Safety Concerns for Ocaliva in Treating Rare Liver Disease

The Food and Drug Administration (FDA) has raised new safety concerns regarding Ocaliva, a drug used to treat primary biliary cholangitis (PBC), a rare liver disease. The FDA identified 20 serious cases of liver damage, including liver transplants, listings for transplants, or liver-related deaths among patients treated with Ocaliva. These findings come after a review of clinical trial data, notably affecting patients without cirrhosis, a condit…

'Serious liver injury' cases lead FDA to call for monitoring of Ocaliva patients

The FDA said it continues to monitor the safety of Intercept Pharmaceuticals and Alfasigma’s rare liver disease drug Ocaliva after seeing evidence of “serious liver injury” in a post-approval clinical trial. The agency announced Thursday ...